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United States·US-MF-000002301
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1001, Murry Ridge Lane, Murrysville, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Melissa Rosko
- EUDAMED SRN
- US-MF-000002301
- FDA FEI Number
- 3007220521
- DUNS Number
- 080728314
Catalogue (3774)
Page 18 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation Cellular Modem, US | FDA UDI | Class I | Active |
| BiPAP | CN657S | FDA UDI | Class II | Active |
| zRIP | zRIP Durabelt Kit, Pediatric, A5 | FDA UDI | Class II | Active |
| DreamStation AutoSV, Ukraine | 00 | FDA UDI | Class II | Active |
| DreamStation autoSV | DreamStation BiPAP autoSV w/humid w/h tube, no bluetooth, LA | FDA UDI | Class II | Active |
| DreamMapper App iOS | 2.11 | FDA UDI | Class II | Active |
| BiPAP A40 | FRX3100T14 | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with Standard Battery, INTL | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex w/Humidifier, Sys One 60 Srs, NO | FDA UDI | Class II | Active |
| DreamMapper | DreamMapper Web Software, North America Instance - 2 | FDA UDI | Class II | Active |
| Trilogy Evo | CA2110X12B | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| EverFlo | EverFlo, w/Oxygen Percent Indicator, 230V, UltraFill, UK | FDA UDI | Class II | Unknown |
| DreamStation | 00 | FDA UDI | Class I | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgr, Lab, Large, USA | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series Core Pack w/Heated Tube, AHP | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Mask with Headgear, Disposable, Medium, USA | FDA UDI | Class II | Active |
| Trilogy Evo | AU2110X15B | FDA UDI | Class II | Active |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, IT | FDA UDI | Class II | Unknown |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| Wisp | 1118064 | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, DE | FDA UDI | Class II | Unknown |
| Wisp | Wisp Mask, Clear Frame, without headgear, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus, w/H Tube Humid, 60 Series, CA | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto, BR | FDA UDI | Class II | Unknown |
| DreamStation BiPAP AVAPS | DreamStation AVAPS 25, no Bluetooth, Intl | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go CPAP with Bluetooth, AU | FDA UDI | Class II | Active |
| Sensor | PLM Sensor, 249 | FDA UDI | Class II | Active |
| Trilogy | Trilogy 100 w/Bluetooth, U.S.A | FDA UDI | Class II | Unknown |
| DreamStation | 00 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus with Humidifier, INTL | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation AVAPS 25 w/Heated Humidifier, No Bluetooth, EU | FDA UDI | Class II | Active |
| Pro-Flow | PRO-FLOW Plus Nasal Oral Cannula Adult 7' | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 1, Large, INTL | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, M, S-M-L Connector w/HDGR, JN | FDA UDI | Class II | Unknown |
| Alice 5 | BODY POSITION SENSOR, ALICE 5 | FDA UDI | Class II | Active |
| System One 60 Series | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto, CA | FDA UDI | Class II | Active |
| EverFlo | EVERFLO w/Oxygen Percentage Indicator, 120V, L.A | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME AND RS Headgear, Small, US | FDA UDI | Class II | Active |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak1 with CapStrap, Medium, China | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | BiPAP AVAPS C Series, Synchrony | FDA UDI | Class II | Active |
| Hl7 | Software, HL7 Sleepware G3, Web - 3 | FDA UDI | Class I | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, AU | FDA UDI | Class II | Active |
| BiPAP A40 | CAX3000S12 | FDA UDI | Class II | Active |
| Care Orchestrator Essence Software | 3.1 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation autoSV with Humidifier, no Bluetooth, LA | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Respironics, Inc. Coyol Alajuela · CR FEI 3027553886